# ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 41
- 510(k) review time 2021–2025: median 115 days (middle half 67–268)
- Recalls: 50 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 3
- 2017: 2
- 2018: 6
- 2019: 1
- 2020: 3
- 2021: 3
- 2022: 1
- 2023: 3
- 2024: 8
- 2025: 6

## Most-cited predicates
- K123213: BD Phaseal Closed System Transfer Device (2013), cited by 9
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), cited by 4
- K192866: Chemfort CSTD (2020), cited by 3
- K130197: BD Phaseal Closed System Transfer Device - P55 (2013), cited by 3
- K240171: ProSeal™ Injector Plus (Model no. 421050) (2024), cited by 3
- K181221: BD PhaSeal Optima Closed System Transfer Device (2018), cited by 2
- K170706: Equashield Closed System drug Transfer Device (CSTD) (2017), cited by 2
- K241988: ProSeal™ Closed System Bag Access (2024), cited by 2
- K241476: ToxiSeal™ Vial Adaptor with External Flip Balloon (2024), cited by 1
- K150219: Equashield Closed System drug Transfer Device (CSTD) (2015), cited by 1

Source page: https://510kreport.com/product-code/ONB
Data by year (CSV): https://510kreport.com/product-code/ONB.csv